CLASSIFICATION & STATUS
Product information
- Intended purpose (planned)
- PHASE is intended to support the systematic documentation of the course of mood, energy and related parameters in people with bipolar disorder (ICD-10: F31) and to structure communication with clinicians. PHASE is currently a prototype and not an approved medical device.
- Project status
- Working prototype in active development and pilot use. Approval as a medical device and listing in the DiGA directory of the BfArM (German Federal Institute for Drugs and Medical Devices) are being pursued but have not yet been granted.
- Instructions for use
- Will be published with the first version ready for approval.
- UDI-DI (Unique Device Identification)
- Will be assigned with approval.
- Software version
- Will be set with the first release.
- Responsible
- Felix Brudler, Jonas Schneider